CHORUS POLIOVIRUS IgG 81264

GUDID 08033891329631

DIESSE DIAGNOSTICA SENESE SPA

Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08033891329631
• NIH Device Record Key: 166f9ac5-3d44-406d-b615-b85341aec232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHORUS POLIOVIRUS IgG
• Version Model Number: 81264
• Catalog Number: 81264
• Company DUNS: 435036669
• Company Name: DIESSE DIAGNOSTICA SENESE SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033891329631 [Primary]

FDA Product Code

• GOH: Antigens, Cf (Including Cf Control), Poliovirus 1-3

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-30
• Device Publish Date: 2024-01-22

Devices Manufactured by DIESSE DIAGNOSTICA SENESE SPA

• 08033891320010 - CHORUS ECHINOCOCCUS IgG: 2024-01-30
• 08033891320522 - VACU-TEC: 2024-01-30
• 08033891320645 - VACU-TEC CUVETTE-L: 2024-01-30
• 08033891320690 - VES-TEC CUVETTE-L: 2024-01-30
• 08033891321086 - VACU-TEC S.C.: 2024-01-30
• 08033891321093 - VACU-TEC S.C. STERILE: 2024-01-30
• 08033891322083 - CHORUS Q FEVER PHASE II IgG: 2024-01-30
• 08033891322434 - CHORUS MEASLES IgG: 2024-01-30